Inflatable medical interfaces and other medical devices, systems, and methods

ABSTRACT

An inflatable mask with two ocular cavities can seal against a user&#39;s face by forming an air-tight seal around the periphery of the user&#39;s eye socket. The sealed air-tight ocular cavity can be pressurized to take ocular measurements. The mask can conform to the contours of a user&#39;s face by inflating or deflating the mask. In addition, the distance between the user and a medical device (e.g. an optical coherence tomography instrument) can be adjusted by inflating or deflating the mask. Also disclosed herein is an electronic encounter portal and an automated eye examination. Other embodiments are also described.

BACKGROUND OF THE INVENTION

1. Field of the Invention

Embodiments of the invention relate to the field of healthcare,including for example, devices, systems, methods of automating theprovision of diagnostic healthcare services to a patient as part of anexamination meant to detect disorders or diseases. In some but not allinstances, these healthcare services may apply only to eye careencounters, exams, services and eye diseases.

2. Description of the Related Art

Many people visiting medical offices often use the same equipment.Cross-contamination has become a problem of increasing concern,especially during certain periods such as flu season. As the provisionof healthcare becomes more automated, fewer office personnel may bepresent to clean devices between uses. Accordingly systems and methodsfor improving hygiene are desirable.

SUMMARY OF THE INVENTION

A wide range of embodiments are described herein. In some embodiments, amask may comprise a distal sheet member having one or more substantiallyoptically transparent sections and a proximal inflatable member having agenerally rear concaved surface that may face a first patient's facewhen in use. The rear concaved surface may be configured to conform tocontours of the first patient's face. The inflatable member may have twocavities therein. The two cavities may be generally aligned with the oneor more substantially optically transparent sections, and may extendfrom the rear concaved surface toward the distal sheet member such thatthe cavities define two openings on the rear concave surface. The rearconcave surface may be configured to seal against the first patient'sface such that the first patient's eyes align with the two cavities, sothat the rear concave surface forms seals around a peripheral region ofthe first patient's eye sockets that inhibit flow of fluid into and outof the cavities. The mask may further comprise an ocular port providingaccess to at least one of the two ocular cavities for fluid flow intoand out of the at least one of the two ocular cavities and an inflationport providing access to inflate the inflatable member.

In various embodiments, the rear concaved surface may be configured toconform to the contours of the first patient's face with inflation ofthe inflatable member via the inflation port. The inflatable member maybe underinflated and the rear concaved surface may be configured toconform to the contours of the first patient's face with inflation ofthe underinflated inflatable member via the inflation port. The rearconcaved surface may be configured to conform to the contours of thefirst patient's face with application of negative pressure to theinflatable member via the inflation port. The mask may further compriseparticulate matter disposed within the inflatable member. Theparticulate matter may be configured to pack together with applicationof a negative pressure to the inflatable member via the inflation port,so that the rear concaved surface conforms to the contours of the firstpatient's face.

In various embodiments, the rear concaved surface may be configured toconform to contours of a second patient's face, wherein a contour of thesecond patient's face is different from a contour of the first patient'sface. The seals may be air-tight. The mask may further comprise a lipextending into at least one of the two cavities from a perimeter of atleast one of the two openings, the lip having distal ends curving towardthe distal sheet member in a default position, the distal endsconfigured to move rearwardly such that the lip seals against the user'sface upon introduction of positive pressure into the at least one of thetwo cavities. The inflatable member may be opaque.

In various embodiments, the distal sheet may be configured to interfacewith a medical device, which may be an eye exam device. The mask may beconfigured to couple with a docking portion on a medical device. Themask may be configured to couple with the docking portion via a flangethat slides into a slot of the docking portion. The inflation port andthe ocular port of the mask may be configured to couple with conduitends on a medical device. The ocular port and the inflation port mayinclude a male portion, wherein the conduit ends on the medical deviceinclude a female portion configured to slidably receive the maleportion. The ocular port and the inflation port may be configured tocouple with the conduit ends on the medical device substantiallysimultaneously.

Some embodiments of the invention relate to the utilization of devicesthat replace, augment or enhance human laborers in a clinical healthcare setting. These devices may be used alone or in conjunction withother devices used in exams such as exams of the eye.

For purposes of this summary, certain aspects, advantages, and novelfeatures of the invention are described herein. It is to be understoodthat not necessarily all such aspects, advantages, and features may beemployed and/or achieved in accordance with any particular embodiment ofthe invention. Thus, for example, those skilled in the art willrecognize that the invention may be embodied or carried out in a mannerthat achieves one advantage or group of advantages as taught hereinwithout necessarily achieving other advantages as may be taught orsuggested herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features, aspects and advantages of the presentinvention are described in detail below with reference to the drawingsof various embodiments, which are intended to illustrate and not tolimit the invention. The drawings comprise the following figures inwhich:

FIG. 1 schematically illustrates a perspective view of one embodiment ofa mask which is inflatable and includes a framework that forms twocavities for the oculars.

FIGS. 2 a-2 b schematically illustrates a mask removably attached to amedical device.

FIG. 3 schematically illustrates a user wearing a mask that provides,for example, an interface to a medical device such as a diagnosticdevice that is used by many patients.

FIG. 4 schematically illustrates a perspective view of anotherembodiment of a mask with an inflatable framework that is partitionedinto two separately inflatable sections.

FIG. 5 schematically illustrates a cross section of the mask in FIG. 4taken along the lines 5-5.

FIG. 6 schematically illustrates a perspective view of anotherembodiment of a mask with a seal around the ocular cavities.

FIG. 7 a schematically illustrates a side view of one embodiment of amask displaced a first distance from a medical device.

FIG. 7 b schematically illustrates a side view of another embodiment ofa mask displaced a second distance from the medical device.

FIG. 8 schematically illustrates a schematic diagram of a system forcontrolling, monitoring, and providing fluid to a mask.

FIG. 9 schematically illustrates a schematic diagram an electronic examportal.

FIG. 10 schematically illustrates a healthcare office map.

FIG. 11 schematically illustrates a block diagram of a sample healthcareencounter.

FIG. 12 schematically illustrates a binocular eye examination systembased on optical coherence tomography.

FIG. 13 schematically illustrates a display of eye examination data.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Some embodiments disclosed herein provide an inflatable mask that caninterface with medical devices, such as medical diagnostic devices, suchas optical coherence tomography (“OCT”) devices. The inflatable mask canserve a variety of purposes, including maintaining a barrier between thepatient and the medical device to ensure cleanliness and hygiene,providing comfort to the patient, and stabilizing the patient's locationwith respect to the machine. In some embodiments, the inflatable maskcan form air-tight ocular cavities around the patient's eyes, allowingfor pressurization of the ocular cavities, in order to obtain ocularmeasurements. Additionally, various embodiments of an automatic portalsystem and an automated eye examination are disclosed herein.

Embodiments of the invention will now be described with reference to theaccompanying figures, wherein like numerals refer to like elementsthroughout. The terminology used in the description presented herein isnot intended to be interpreted in any limited or restrictive manner,simply because it is being utilized in conjunction with a detaileddescription of certain specific embodiments of the invention.Furthermore, embodiments of the invention may comprise several novelfeatures, no single one of which is solely responsible for its desirableattributes or which is essential to practicing the embodiments of theinventions herein described.

Inflatable Medical Interface

Referring to FIG. 1, in one embodiment, a mask 100 includes a distalsheet member 118 which has optically transparent sections 124, and aproximal inflatable member 154 having a generally concaved rear surface122. In use, the rear concaved surface 122 faces the patient's face andconforms to the patient's face, according to some embodiments of theinvention. As used herein the terms “user” or “patient” or “subject” or“wearer” may be used interchangeably. Still Referring to FIG. 1, theinflatable member 154 can have two cavities 160 a, 160 b which arealigned with the optically transparent sections 124. In someembodiments, the cavities 160 a, 160 b extend from a distal sheet 118 tothe rear concave surface 122 and define two openings 162 on the rearconcave surface 122. In use, the patient's eyes align with the twocavities 160 a, 160 b, so that the rear concave surface 122 forms sealsaround the patient's eye sockets or face, e.g. forehead and cheeks,inhibiting flow of fluid into and out of the cavities 160 a, 160 b. Inaddition, the mask 100 can include ports 170 a-b, 180 a-b which provideaccess to control flow of fluid (e.g. air) into and out of the cavities160 a, 160 b.

In some embodiments, the mask 100 can interface with a medical device.With reference to FIGS. 2 a-2 b, there is illustrated one embodimentwhereby the mask 100 is placed on a separate device 112. In someembodiments, the separate device 112 is a medical device, such as adiagnostic or therapeutic device. In some embodiments, the separatedevice 112 is an ophthalmic device, such as a device for the eye, andmay be an optical coherence tomography device (“OCT”) that may contain ahousing and instrumentation contained therein. The mask 100 may be usedwith a wide range of medical devices 112, such as for example an OCTdevice such as disclosed herein, as well as other OCT devices and othermedical devices 112. In some embodiments, the medical device 112 canreceive and removably connect to the mask 100. The mask 100 can beconfigured to connect to the medical device 112, adhere to one or moresurfaces of the medical device 112, or be mechanically fixed to themedical device 112, or be secured to the medical device 112 in any otherway (e.g. clamps, straps, pins, screws, hinges, elastic bands, buttons,etc.), such that the mask 100 is removable from the medical device 112without damaging the mask 100.

In one embodiment, a docking portion 114, which may include an opticalinterface such as for example a plate, can be included on the medicaldevice 112. The docking portion 114 can also include a slot 116 forreceiving a mask 100. In some embodiments, the mask 100 includes aflange 164 that extends laterally outward past a side of the inflatablemember 154 on the distal sheet 118 for slideably engaging with the slot116. The mask 100 can be inserted into the slot 116 and slide down to afinal locking position 120. In another embodiment, the flange 164 can beon the medical device 112 and the slot 116 can be on the mask 100.

With reference to FIG. 3, there is illustrated an example of a mask 100worn by a user over the user's eyes. In various embodiments, the mask100 may be removably attached to the wearer with an adhesive, an elasticband, a Velcro band, a strap, a buckle, a clip, and/or any othersuitable fastener or mechanism. In some embodiments, the mask 100 caninclude mechanisms for both attaching to the wearer and attaching to themedical device 112. In other embodiments, a patient may use the mask 100without any straps, bands, etc. that attach to the user. For example,referring to FIGS. 2 a-b, the patient may simply move his/her face inalignment and in contact with the mask 100, which is secured to themedical device 112. In another embodiment, a patient who has a mask 100secured to his/her face may position himself/herself properly withrespect to the medical device 112, so that the distal sheet 118interfaces with the medical device, 112, and the medical device 112 cantake readings.

Returning to FIG. 1, one embodiment of the mask 100 comprises aninflatable framework 154 having an inflatable chamber 154 a, twocavities 160 a, 160 b, a frontward surface formed by a distal sheetmember 118, and a rearward surface 122. It will be understood that“inflatable,” as used herein, can include “deflatable,” and vice versa.Thus, in some embodiments, an “inflatable” framework 154 or chamber 154a can be deflatable, and a “deflatable” framework 154 or chamber 154 acan be inflatable. Referring to FIG. 1, cavities 160 a, 160 b may extendbetween the distal sheet member 118 and the rearward surface 122. Insome embodiments, the frontward member 118 includes a window member 124,which can be substantially optically transparent in some embodiments,with minimal to no effects on the optics of a medical device 112 (e.g.an OCT device) which can interface with the mask 100, although someembodiments may introduce optical effects. In some embodiments, thedistal sheet member 118 can be rigid. In some embodiments, the distalsheet member 118 can be made of polycarbonate, poly(methylmethacrylate), or glass. Other materials can be used. In otherembodiments, the distal sheet member 118 can be flexible. The distalsheet member 118 can have a thickness of less than 0.1 mm, 0.1 mm, 0.5mm, 1 mm, 2 mm, 4 mm, or more. In one embodiment, the window member 124may be adjacent to the inflatable framework 154. Thus, the window member124 may form a frontward surface of a cavity 160 a, 160 b. Further, thewindow member 124 may be aligned with the cavities 160 a, 160 b. Inaddition, the cavities 160 a, 160 b can define openings on the rearwardsurface, defined by perimeters 162. Referring to FIG. 4, the inflatableframework 154 can have two separately inflatable chambers 150 a, 150 b.Still referring to FIG. 4, in one embodiment, one inflatable chamber 150a can have a cavity 160 a therein, and another inflatable chamber 150 bcan have another cavity 160 b therein.

The distal sheet member 118 may be substantially flat and the rearwardsurface 122 may be generally curved and concave according to oneembodiment of the invention. Referring to FIG. 4, in one embodiment thethickness of the mask 100 is thinnest at the center 156 and thickesttoward the outer edges 158, with the thickness decreasing from the outeredges 158 toward the center 156, thereby defining a curved and concaverearward surface 122.

During use, a patient's face is brought in contact with the rearwardsurface 122 of the mask, such that the patient's eyes are aligned withthe cavities 160 a, 160 b, and the patient “sees” into the cavities 160a, 160 b. Thus in some embodiments, the cavities 160 a, 160 b may bereferred to as ocular cavities 160 a, 160 b. In one embodiment, only theportion of the distal sheet member 118 that aligns with the patient'seyes may be optically transparent, with other portions opaque ornon-transparent.

In some embodiments, the rear concaved surface 122 of the mask 100 canseal against a patient's face around the general area surrounding thepatient's eyes sockets, thereby forming a seal around the patient's eyesockets. The seal may be air-tight and liquid-tight according to someembodiments of the invention. In some embodiments, a seal may be formedbetween the user and the mask 100 without the need for assistance fromadditional personnel. In some embodiments, various portions of thepatient's face can form the seal around the ocular cavities 160 a, 160b. For example, the patient's forehead, cheekbones, and/or nasal bridge(e.g. frontal bone, supraorbital foramen, zygomatic bone, maxilla, nasalbone) can form a seal around the ocular cavities 160 a, 160 b. As usedherein, reference to a “peripheral region” around the eye socket shallrefer to any combination of the above.

FIG. 5 illustrates a top view of a patient wearing a mask 100. The mask100 in FIG. 5 is a cross-section of the mask 100 taken along line 5-5 inFIG. 4. Referring to FIG. 5, as seen from the view of the patient, themask 100 comprises a right cavity 160 b, such as a right ocular rightcavity, a left cavity 160 a, such as a left ocular cavity, a rightinflatable chamber 150 b, and a left inflatable chamber 150 b. The walls172 of the ocular cavities 160 a, 160 b, the window members 124, and thehead of the user 195 may form an air-tight enclosed area. The head ofthe user 195 (e.g. the peripheral region around the user's eye sockets)forms a seal with the rearward perimeters 162 of the cavities 160 a, 160b, thus allowing the cavities 160 a, 160 b to hold air or fluid. Thisseal may be capable of holding air or fluid pressures of, for example,0.5 psi, 1 psi, or 5 psi or pressures therebetween. Higher or lowerpressures are also possible.

Still referring to FIG. 5, some embodiments of the invention includeinlet assemblies 155 a, 155 b. The inlet assemblies may include ports170 a-b, 180 a-b, allowing access to the inflatable chambers 150 a, 150b, and/or the cavities 160 a, 160 b.

Air, fluid, and/or other substances can be introduced into the ocularcavities 160 a, 160 b, via ports 180 a, 180 b, 185 a, 185 b. Air may beintroduced into the left ocular cavity 160 a by supplying an air source(e.g. via a pump) to the port at 180 a. Thus, following the path of theair, the air may enter the port at 180 a, then exit the port at 185 aand into the leftocular cavity 160 a (180 a and 185 b represent two endsof the same path). Similarly, regarding the right ocular cavity 160 b,air may enter the port at 180 b, then exit the port at 185 b and intothe right ocular cavity 160 b.

Accordingly, in some embodiments, pressure inside the ocular cavities160 a, 160 b may be controlled by adjusting the amount of air into andout of the ports 180 a, 180 b. Further, the air tight seal formedbetween the patient's face and the mask 100 can prevent unwanted leaksinto or out of the ocular cavities 160 a, 160 b. This can beadvantageous when air or fluid is used to challenge or test a bodyfunction. For example, air pumped into sealed air chamber cavities 160a, 160 b in front of the eye can create positive pressure which can beused to press on the eye for the purposes of measuring the force ofglobe retropulsion or measuring intraocular pressure. In addition, aircan be directed to the cornea, which is imaged with OCT. In someembodiments, air is pumped into the ocular cavities 160 a, 160 b toachieve a pressure of up to 1-2 psi. In some embodiments, the airsupplied to the ocular cavities 160 a, 160 b is supplied by ambientsurroundings, such as the ambient air in a clinical room using forexample a pump.

In some embodiments, chamber ports 170 a, 170 b, 175 a, 175 b provideaccess to inflatable chambers 150 a, 150 b for inflating or deflatingthe chambers 150 a, 150 b. The chambers 150 a, 150 b may be inflated byintroducing an air source (e.g. via a pump) to the ports at 170 a, 180a. Thus, for example, following the path of the air, the air may enterthe port at 170 a, then exit the port at 175 a and into the leftinflatable chamber 150 a, thereby inflating that chamber 150 a. Theright chamber 150 b may be inflated in a similar manner. Negativepressure (e.g. a vacuum) can be applied to the ports 170 a, 170 bconnected to the inflatable chambers 150 a, 150 b, thereby deflating thechambers 150 a, 150 b. As used herein, “deflating” shall includeapplying negative pressure.

In some embodiments, inflating the chambers 150 a, 150 b can cause themask 100 to conform to the contours of a user's face. In addition,deflating the chambers 150 a, 150 b can cause the mask 100 to conform tothe contours of a user's face. Further, inflating or deflating thechambers 150 a, 150 b can adjust a thickness of the mask 100, thuschanging the distance between a user (who may face the rear concavedsurface 122) and a medical device 112 (which may be interfaced with thedistal sheet member 118).

In various embodiments, a port 170 a-b, 180 a-b is provided for eachchamber 150 a, 150 b and cavity 160 a, 160 b. For example, referring toFIG. 5, there is illustrated a port 185 b for the right cavity, a port175 b for the right inflatable chamber 150 b, a port 185 a for the leftcavity 160 a, and a port 175 a for the left inflatable chamber 150 a.

In one embodiment, two ports may be provided for one inflatableframework 154. For example, returning to FIG. 1, one port 170 b isprovided on the right side of the inflatable framework 154, and anotherport 170 a is provided on the left side of the inflatable framework 154.Providing two ports for one chamber 154 can help to equalize thedistribution of substances (e.g. air or fluid) in the chamber 154 byallowing access to the chamber 154 at different regions.

In one embodiment, the inflatable framework 154 does not include anyports. For example, the inflatable framework 154 may be pre-formed asdesired, by filling it with a desired volume of fluid or air. Ports 170a-b, 180 a-b may be added, removed, arranged, or configured in anysuitable manner.

In some embodiments, the mask 100 advantageously can conform to apatient's face, thereby allowing the formation of a complete air-tightseal between the peripheral region around a user's eye sockets and therear concaved surface 122 around the ocular cavities 160 a, 160 b.Accordingly, the rearward perimeter 162 of the cavities 160 a, 160 b canbe configured to sealingly engage a periphery of a patient's eye socket.In some embodiments, the mask 100 includes a recess 168 (see e.g. FIGS.1, 4, 6), allowing room for a patient's nose, so that the mask 100 formsa seal against the parts of a patient's face with a lower degree ofcurvature, increasing the surface area of the patient's face to whichthe mask 100 conforms.

In one embodiment, the air-tight seal can be formed by inflating theinflatable framework 154. In some embodiments, the inflatable framework154 can resemble a bag. In some embodiments, a mask 100 with arelatively deflated framework 154 is provided to a patient. Because thebag 154 is deflated, it may exhibit some “slack.” The patient's face maybe brought in contact with the mask 100, and then the bag 154 may beinflated, causing the bag 154 to inflate around the contours of thepatient's face and thereby conform to the patient's face. Accordingly, acomplete air-tight seal can be formed between the patient's face and therear concaved surface 122 around the ocular cavities 160 a, 160 b. Thebag 154 may be inflated by introducing air, gas, fluid, gel, or anyother suitable substance. In addition, the bag 154 can be deflated,causing the mask 100 to disengage from the patient's face, according toone embodiment of the invention.

In one embodiment, an air-tight seal is formed by applying a vacuum tothe inflatable framework 154. In some embodiments, when the framework154 is filled with particulate matter, such as coffee grounds, aplasmoid transformation to a semi-solid but form-fitting filler can beachieved by subjecting the particulate matter to a vacuum. For example,the framework 154 can be molded into shape easily when particulatematter is loosely contained in the framework 154, similar to a bean bag.A patient's face may then be brought into contact with the mask 100.Applying a vacuum to the bag 154 causes the particulate matter to packtightly, thereby causing the bag 154 to conform to the contours of apatient's face. The tightly packed particulate matter can thus undergo aplasmoid transformation to a solid, while still allowing the framework154 to conform to the patient's face and create an air-tight seal.

To facilitate the seal between a patient and the cavities 160 a, 160 b,the mask 100 can be configured with a lip 194 around the perimeter 162of a cavity 160 a, 160 b, as illustrated in FIG. 6. FIG. 6 illustrates alip 194 with a cut-away portion 161 showing the curvature of the lip194. In one embodiment, the lip 194 comprises a first end 196 attachedto the perimeter 162 of the cavity 160 a, 160 b and a second end 198extending partially into the cavity 160 a, 160 b. In one embodiment, theedge 198 of the lip 194 may extend more or less and curl inward, asillustrated in FIG. 6. In one embodiment, the first end 196 and secondend 198 define a curve, such that the lip 194 curls inwardly partiallyinto the cavity 160 a, 160 b. Further, the lip 194 can be flexible andconfigured to extend in a rearward direction (e.g. toward the rearwardsurface 122). Thus, when pressure is introduced inside the cavity 160 a,160 b, and pressure exerts a force in a rearward direction, the lip 194can move rearwardly. When the inflatable framework 154 is sealed with aperipheral region around a user's eye socket, and the lip 194 movesrearwardly, the lip 194 can seal against the user's eye socket,preventing pressure from escaping.

In some embodiments, the mask 100 can be configured to be comfortable byfilling the chambers 160 a, 160 b with soft gel fillers, particulatefillers such as foam beads or sand, or air fillers.

In one embodiment, the mask 100 can be custom made to fit the specificpatient using it. For example, the mask 100 may be molded for a specificpatient in a clinic. Thus, the mask 100 can be uniquely customized for aparticular patient according to one embodiment. In another embodiment,the mask 100 is a “one size fits all” mask 100. Other embodiments arepossible, including differential sizing based on age, height or facialstructure. In some embodiments, the mask 100 is pre-inflated. Inaddition, air-tight seals can be formed between the rear curved surface122 of the mask around the ocular cavities 160 a, 160 b and theperipheral region around a patient's eye sockets (e.g. via a lip) whenthe mask 100 is pre-inflated.

FIGS. 7 a-7 b illustrate side views of a user with a mask 100 beingexamined or treated by a medical device 112 according to one embodimentof the invention.

It will be appreciated that the FIGS. 7 a-7 b are schematic drawings andmay possibly exaggerate the variation in size for illustrative purposes.The medical device 112 shown in FIGS. 7 a-7 b can be an OCT device.Inflating the mask 100 can increase the thickness of the mask 100, sothat the mask 100 can move the patient toward or away from the device112 when it is deflated or inflated respectively. For example, FIG. 7 aillustrates a relatively deflated mask 100, with a user relatively closeto the device 112. FIG. 7 b illustrates a relatively inflated mask 100,with the user relatively farther from the mask 100. “Inflating” or“inflated” may include a mask 100 in a fully inflated state, or a mask100 in a less than fully inflated state, but still in a state that ismore inflated relative to a previous state (e.g. a deflated state) or atleast partially inflated. Similarly, “deflating” or “deflated” mayinclude a mask 100 in a fully deflated state, or a mask 100 in a lessthan fully deflated state, but still in a state that is more deflatedrelative to a previous state (e.g. an inflated state) or at leastpartially deflated.

A patient location sensor 166 can be included in order to detect howclose or how far the user is from the medical device 112. If the user isnot at a desired distance from the device 112, the framework 154 on themask 100 can be inflated or deflated to bring the user to the desireddistance. Any variety of sensors 166 can be used to detect the distancebetween the user and the medical device 112, according to sensors knownin the art. In one embodiment, a patient location sensor 166 can beincluded with the medical device 112 in alignment with the user'sforehead, as illustrated in FIGS. 7 a-7 b. Thus, the location sensor 166can measure, for example, the distance or relative distance from theforehead to the medical device 112. In one embodiment, the sensor 166can be a switch, which can be actuated (e.g. activated or depressed)when the user's forehead presses against the switch when the user isclose to the medical device 112. In addition, other types of sensors indifferent locations could measure the distance between the user and themedical device 112. In one embodiment, the location sensor 166 is notplaced on the medical device 112, but is placed in a location that canstill detect the distance between the user and the medical device 112(e.g. on the walls of a room in which the medical device 112 islocated). In one embodiment, the information regarding the distancebetween the user and the medical device 112 is provided by an OCTdevice.

FIG. 8 illustrates a system 174 for controlling, monitoring, andproviding air to the inflatable mask 100. The system 174 can be used tocontrol a patient's distance from the medical device 112, the patient'smovement to and from the medical device 112, the seal between the mask100 and the patient's face, and/or pressure in the ocular cavities 160a, 160 b of the mask 100.

Referring to FIG. 8, the system 174 can include pumps 176, an air source176, conduits 178, valves 182, pressure sensors 188, flow sensors 188and/or processors (not shown). In addition, air into and out of theinflatable chambers 150 a, 150 b and/or cavities 160 a, 160 b can becontrolled by similar components. Referring to FIG. 7 b, the airsource/pump 176, valves 182, sensors 188, and the mask 100 can be influid communication with each other via conduits 178. In addition, theair source/pump 176, valves 182, and sensors 188 can be in electroniccommunication with a processor. Further, the processor can be incommunication with electronics associated with a medical device 112,such as an OCT device.

In some embodiments, the air source/pump 176, conduits 178, valves 182,sensors 188, and processors can be contained within a single unit, suchas a medical device 112. In other embodiments, the components may bespread out across several devices external to a medical device 112.

Referring to FIG. 8, the mask 100 can be connected to an air source/pump176, which can comprise compressed air, ambient air from the environmentof the mask (e.g. in a clinical room), a reservoir, a sink (e.g. forproviding water to the mask 100), an automatic pump, manual pump, handpump, dispenser, or any other suitable air source/pump.

Valves 182 can also be included in the system 174 for increasing,decreasing, stopping, starting, changing the direction, or otherwiseaffecting the flow of air within the system 174. In some embodiments,the valves 182 can direct air to an exhaust port, in order to vent airin the cavities 160 a, 160 b or inflatable chambers 150 a, 150 b. Insome embodiments, valves 182 are not included in the ports 170 a-b, 180a-b of the mask 100, and are external to the mask 100. In someembodiments, valves 182 can be included in the ports 170 a-b, 180 a-b ofthe mask 100.

In some embodiments, the system can also include an ocular pressuresensor 186 to sense the pressure inside the ocular cavities 160 a, 160b. Readings from the pressure sensor 186 can be used for intraocularpressure and retropulsion measurements. In addition, the system 174 caninclude a chamber pressure sensor 184. In some embodiments, the chamberpressure sensor 184 can be used to determine whether a patient ispressing their face against the mask 100, or how hard the patient ispressing their face against the mask 100.

A flow sensor 188 can also be provided to measure the volume of flowinto and out of the ocular cavities 160 a, 160 b and inflatable chambers150 a, 150 b. Flow sensors 188 may be useful when, for example, theinflatable chamber 150 a, 150 b is under-inflated such that the pressureinside the inflatable chamber equals atmosphereic pressure. In such acase, pressure sensors 188 may not be useful but a flow sensor 188 canmeasure the volume of fluid pumped into the inflatable chamber 150 a,150 b. In some embodiments, one set of sensors can be provided for theocular cavities 160 a, 160 b, and another set of sensors can be providedfor the inflatable chambers 150 a, 150 b.

Referring to FIG. 8, the conduits 178 can convey the flow of air (orgas, liquid, gel, etc.) between the pump/air source 176, valves 182,sensors 188, and the mask 100. In some embodiments, the valves 182 canbe downstream of the pump/air source 176, the sensors 188 can bedownstream of the valves 182, and the mask 100 can be downstream of thesensors 188.

In some embodiments, the conduit 178 terminates at conduit ends 192,shown in FIGS. 2 a-2 b. The conduit ends 192 can be designed to couplewith the ports 170 a-b, 180 a-b of the mask 100. Referring to FIGS. 2a-b, in some embodiments, the ports 170 a-b, 180 a-b of the mask 100 caninclude a male portion (e.g. a luer lock taper connector), and theconduit ends 192 can include a female portion.

In some embodiments, the ports 170 a-b, 180 a-b of the mask 100 caninclude a female portion, and the conduit ends 192 can include a maleportion. In addition, the conduit ends 192 and the ports 170 a-b, 180a-b can contain flanges, tubings, or any other mechanism for couplingwith each other. When the ports 170 a-b, 180 a-b are coupled to theconduit ends 192, an air-tight seal for fluid flow between the mask 100and the system can be created.

Referring to FIG. 2 a, in some embodiments, one movement (e.g. pressingthe mask 100 down in the direction of the arrow 199) can connect allfour ports 170 a-b, 180 a-b to the conduit ends 192 at the same time. Insome embodiments, the conduit ends 192 extend to the exterior of themedical device 112, and the conduits 178 can be connected to theexterior ports 170 a-b, 180 a-b one at a time. In some embodiments, theconduits ends 192 are located on the medical device 112, and a separateconduit piece can connect the conduit ends 192 to the external ports 170a-b, 180 a-b.

In some embodiments, the system 174 can be used in clinical settings,such as during a medical visit (e.g. a medical examination). Thecomponents can be utilized in a variety of different ways andcombinations during the medical treatment.

For example, during a medical diagnostic or treatment, referring to FIG.2 a, the mask 100 can be interfaced with the medical device 112 byaligning the ports 170 a-b, 180 a-b of the mask 100 with the conduitends 192 in the medical device 112, and pushing down on the mask 100.

The patient's head can be brought into contact with the rear concavedsurface 122 of the mask 100, and system 174 can inflate or deflate theinflatable chambers 150 a, 150 b, so that the mask 100 conforms to thepatient's face, thereby forming an air-tight seal around the ocularcavities 160 a, 160 b.

During the procedure, the system 174 can change the pressure in theair-tight ocular cavities 160 a, 160 b by a desired amount depending onthe medical examination being taken. The pressure sensor 186 can sensethe amount of pressure in the ocular cavities 160 a, 160 b, and sendthat data to the processor. In addition, the system 174 can vary thepressure in the ocular cavities 160 a, 160 b during the procedure. Forexample, the processor can increase the pump 176 speed or change thevalve state 182 so that flow is restricted.

Other components in the medical device 112 can also take measurements,such as ocular measurements, which can be combined with the data sent bythe pressure sensors. For example, optical imaging components canmeasure changes in curvature or position of the anterior of the eye andin some embodiments, compare those changes to changes in the position orcurvature of posterior of the eye. In addition, changes in the locationsand distances of tissues, such as in the eye, can be imaged based on thepressure in cavities 160 a and 160 b sensed by the pressure sensors.Thus various pieces of data can be analyzed and processed intomeaningful medical information.

Further, during the procedure, the system 174 may receive data from apatient location sensor 166 (see e.g. FIG. 7 a-7 b) indicating thedistance between the patient and the medical device 112. The processormay determine that the patient should be positioned closer to or fartheraway from the medical device 112, in order to obtain more accurate andprecise readings. Thus, the processor may use the location of thepatient to modulate the inflation or deflation of the mask 100 more orless (e.g. by changing pump speed, changing valve state, etc.), in orderto bring the patient closer to or farther away from the medical device112.

In some embodiments, the processor can switch on the pump/air source 176and open the valves 182 to introduce air into the ocular cavities 160 a,160 b or inflatable chambers 150 a, 150 b according to a preset pressureor flow volume goal. In addition, flow in the system can be reversed todeflate the inflatable chambers 150 a, 150 b.

The mask 100 may include a mechanism for easily identifying a patientaccording to one embodiment of the invention. For example, the mask 100may include an RFID tag, bar code or QR code, or other physicalembodiment, to identify the wearer to other devices. Thus, for example,when a patient with a certain mask 100 nears the medical device 112, thesystem can determine who the patient is, and execute instructionstailored for the patient (e.g. how much air is needed to properlyinflate the framework 154, how much pressure should be applied to theocular cavities 160 a, 160 b, what readings the medical device 112should take, etc.)

The mask 100 can be made of a material, such as plastic (e.g.polyethylene, PVC), rubber paper, or any other suitable material. Invarious embodiments, the mask 100 can be configured to be disposable bymaking it out of inexpensive materials such as paper, rubber or plastic.In various embodiments, the mask 100 can be configured to be reusableand easily cleaned either by the wearer or by another person.

In some embodiments, the mask 100 can provide a barrier between thepatient and the medical device 112, increasing cleanliness and servinghygienic purposes.

In one embodiment, the mask 100 can be configured to create a barrier toexternal or ambient light, such as by constructing the mask 100 out ofopaque materials that block light transmission. Accordingly, the mask100 can prevent ambient light from interfering with medical examinationmeasurements, such as optical devices, and ensure the integrity of thosemeasurements.

Although examples are provided with reference to “air” (e.g. introducingair into the inflatable chamber, introducing air into the ocularcavities), it will be appreciated that other substances besides air canbe used, such as gas, fluids, gel, and particulate matter.

Although examples are provided with reference to a mask 100 for abinocular system, it will be appreciated that the embodiments disclosedherein can be adapted for a mono-ocular system. Thus, in one embodiment,the mask 100 includes an inflatable framework 154 defining one cavityinstead of two, and that cavity can form a seal against the periphery ofone eye socket. Further, while examples are provided with reference toeye sockets and eye examinations, it will be appreciated that theembodiments disclosed herein can be used with other tissues and medicalapplications.

In other embodiments, an inflatable device may cover different bodytissues such as gloves for the hands, stockings for the feet or a hatfor the head. In various embodiments, the inflatable device may includea cavity similar to the ocular cavity in the mask and may have at leastone port to provide access to the cavity and change pressure therein orinflow gas therein or outflow gas therefrom, as well as a port toinflate the inflatable devices.

The inflatable mask can be used in a wide variety of clinical settings,including medical examinations and encounters that may be assisted byautomated systems. Various embodiments of an automatic encounter portalare described below.

Electronic Encounter Portal

Medical encounters can be commonly comprised of administrative tasks,collection of examination data, analysis of exam data, and formation ofan assessment and plan by the healthcare provider. In this context, ahealthcare provider may be a licensed healthcare practitioner, such as amedical doctor or optometrist, allowed by law or regulation to providehealthcare services to patients. Examinations may be comprised ofnumerous individual tests or services that provide information for ahealthcare provider to use to make a diagnosis, recommend treatment, andplan follow-up. The data from these tests that are collected for use byhealthcare providers can be broken down into three rough categories:historical data, functional data and physical data.

Historical data can be collected in many ways including as a verbalperson-to-person interview, a written questionnaire read and answered bythe patient, or a set of questions posed by an electronic device eitherverbally or visually. Typical categories of historical information thatare obtained in medical exams can include but are not limited to a chiefcomplaint, history of present illness, past medical history, past ocularhistory, medications, allergies, social history, occupational history,family history, sexual history and a review of systems.

Functional data can be collected through individual tests of functionand can be documented with numbers, symbols or categorical labels.Examples of general medical functions can include but are not limited tomeasurements of blood pressure, pulse, respiratory rate, cognitiveability, gait and coordination. Ophthalmic functions that may be testedduring an exam can include but are not limited to measurements ofvision, refractive error, intraocular pressure, pupillary reactions,visual fields, ocular motility and alignment, ocular sensation,distortion testing, reading speed, contrast sensitivity, stereoacuity,and foveal suppression.

Physical data can capture the physical states of body tissues and can becollected in many forms, including imaging, descriptions or drawings, orother physical measurements. This may be accomplished with simplemeasurement tools such as rulers and scales. It may also be accomplishedwith imaging devices, such as color photography, computed tomography,magnetic resonance imaging, and optical coherence tomography (OCT).Other means to measure physical states are possible. Physicalmeasurements in general medical exams can include height, weight, waistcircumference, hair color, and organ size. Ophthalmic structuralmeasurements can include but are not limited to slit lamp biomicroscopy,retinal OCT, exophthalmometry, biometry, and ultrasound.

Currently, almost all of the individual tests that make up a medicalexamination are conducted by a human laborer often through the operationof a device. Whether this person is a healthcare provider or an alliedhealthcare professional, these laborers can be expensive, can oftenproduce subjective results, and can have limitations on their workingcapacity and efficiency. Given the labor intensive nature of exams,healthcare care practices (which may also be referred to herein as“clinics” or “offices”) and in particular eye care practices oftenemploy numerous ancillary staff members for every healthcare providerand dedicate large areas of office space for waiting rooms, diagnosticequipment rooms and exam rooms. All combined, these overhead costs makehealthcare expensive, inefficient and often prone to errors.

Automation is a well-known way of improving efficiency and capacity aswell as reducing unit costs. Patient-operated or entirely operator-lessdevices may be preferable as labor costs increase and the need forobjective, reproducible, digital, quantitative data increases.

With reference to FIG. 9, there is illustrated one embodiment of anelectronic encounter portal. The encounter module 200 can be anelectronic device that may be comprised of, for example, data storage,communication, or computer code execution capabilities and may containinformation on patients registered for a healthcare encounter in anoffice.

The office interface 210 can be comprised of software that may be usedby people to interact with the encounter module 200. Other software mayalso be included in the office interface 210. In one embodiment, theoffice interface 210 also can be comprised of an electronic device, suchas a computer, tablet device or smartphone. In various embodiments,office staff can use the office interface 210 to, for example, createrecords or enter patient data into the encounter module 200 for patientswho register in the clinic. This data entry can be enabled in many ways,including for example, manual entry, entry by copying previously-entereddata from an office database 220, or entry using a unique identifierthat can be compared to an office database 220 or external database 230,such as an Internet or cloud-based database, to retrieve pre-entereddata for a patient matching that unique identifier. In one embodiment,registration can be completed with a code, such as an encounter code, ina fashion similar to checking in for an airline flight at an airport.This code could, for example, by linked to patient or providerinformation required for registration purposes.

The office database 220 can be configured to store data from pastencounters, as well as other types of data. The external database 230can be also configured to store at least data from past encounters, aswell as other types of data. The encounter module 200 can be configured,for example, to access, copy, modify, delete and add information, suchas patient data, to and from the office database 220 and externaldatabase 230. The external database 230 can be configured to, forexample, receive, store, retrieve and modify encounter information fromother offices.

In one embodiment, patients may self-register or check into the clinicby using the office interface 210 to, for example, create an encounterrecord, enter encounter information manually, select their informationfrom a pre-populated office database 220, or enter a unique identifierthat can be compared to an office 220 or external database 230 toretrieve their other associated data.

The encounter module 200 can be configured to contain patient recordswhich may also contain clinic processes 205. A clinic process 205 can becomprised of, for example, orders from the healthcare provider for thepatient's care. In one embodiment, the orders may indicate the sequenceof evaluations and care. For example, a provider may indicate that agiven patient should undergo a medical history followed by anexamination with various medical devices followed by an assessment bythe provider.

In one embodiment, the clinic process 205 can be configured to enablealteration of the orders, the order sequence or both the orders andtheir sequence by, for example, office staff or the provider. Examplesof this could include insertion of an educational session about a givendisease prior to a discussion with the provider, deletion of a treatmentdenied by a patient, or switching the sequence of two test procedures.

In some embodiments, the prescribed orders themselves may contain listsof prescribed tests to be performed on a given device. For example, aspart of a technician work-up order, a provider may prescribe bloodpressure and pulse measurement testing to be performed on a patientusing a device in the clinic. The order and prescription of these testsmay change throughout the encounter having been altered by office staff,the provider, or electronic devices.

In one embodiment, a diagnosis or medical history of a patient from theencounter module 200 can be included in the clinic process 205 and maybe used, for example, to determine or alter the clinic process 205. Forexample, a history of past visits and evaluations may alter the teststhat are ordered or the devices that are used during an encounter.

In one embodiment of an electronic encounter portal, a tracking system240 can be configured to enable a component of an electronic encountersystem to determine the physical location or position of, for example,patients, providers and staff in the office space. In one embodiment, acomponent of the electronic encounter system can use data from thetracking system 240 to monitor the progress of patients through a clinicprocess 205. In one embodiment, this tracking system 240 can becomprised of a sensing technology, such as a compass, radiofrequencyantenna, acoustic sensor, imaging sensor, or GPS sensor that determinesthe position of the sensor in relation to known objects such as officewalls, positioning beacons, WiFi transmitters, GPS satellites, magneticfields or personnel outfitted with radiofrequency ID tags.

The tracking system 240 may also be configured to perform mathematicalcalculations, such as triangulation, to analyze signals from thesensors. The tracking system may also compare signals from the sensorsto databases of known signals collected at a prior date, such ascomparing a measured magnetic field to a database of known magneticfields at every position in the clinic. In some embodiments, thistracking system 240 can also be comprised of an emission technology suchas a radiofrequency beacon, to indicate the position of an object in theoffice space.

The tracking system 240 may also be configured to localize the positionof a person or object using a known map of the office space as shown inFIG. 3. Knowledge of the position of sensors, patients or personnel inan office space map may enable the tracking system 240 to provideinformation to the encounter module 200 regarding the location ofpatients, providers or other office personnel in an office space.

The tracking system 240 can also be configured to provide positioninformation to other components of the electronic encounter system, suchas the office interface 210 or the patient interface 250, eitherdirectly or via an intermediate component such as the encounter module200. An example of how this information might be used is to providestatus information to a user as to the progress or status of otherpeople in the office.

In one embodiment, office personnel can use the office interface 210 tomonitor the location or progress of, for example, providers, staff orpatients within the office space. This monitoring may includecalculation of, for example, time spent in a given location, progressthrough a clinic process 205, or current status of activity, such aswaiting, working or occupied. This monitoring ability can beadvantageous so that office staff can, for example, monitor delays inthe provision of patient care or identify recurrent patient flowbottlenecks that can be reduced through optimization of clinic flow.

The patient interface 250 can be comprised of software that may be usedby patients to interact with the encounter module 200. In oneembodiment, the patient interface 210 can also comprise an electronicdevice, such as a computer, tablet device or smartphone which can besupplied by the clinic or be supplied by the patient. For the purpose ofclarity, in one embodiment, the patient interface 250 may be thepatient's own electronic device, such as a smartphone or computer, thatcan be configured with patient interface 250 software. In otherembodiments, the office interface 210 and the patient interface 250 maybe the same device, such as with a mobile tablet computer or smartphone,that can be configured to allow a patient to perform actions of both anoffice interface 210, such as registration, and actions of a patientinterface 250, such as viewing patient data or asking electronicquestions of office personnel.

The encounter module 200 and the patient interface 250 can be configuredto interface with various devices 260 in the clinic. These devices 260can include but are not limited to diagnostic instruments, such as bloodpressure monitors, imaging devices or other measurement instruments, ortherapeutic devices, such as lasers or injection apparatuses. Theencounter module and the patient interface 250 can be configured to sendand receive data with these devices 260. Communication with thesedevices 260 can be enabled by but is not limited to wired connections,wireless connections and printed methods, such as bar codes or QR codes.

With reference to FIG. 3, there is illustrated a map of a healthcareoffice. In one embodiment, the patient can register for a healthcareencounter at the office entrance 300. In other embodiments, the patientmay register for a healthcare encounter at a place other than entrance300. In one embodiment, encounter registration can be completed by ahuman receptionist who may enter information into the encounter module200 through the office interface 210. In another embodiment,registration may be completed by the patient for exampleby using anassisted or self-service kiosk configured with an office interface 210.

A kiosk may, for example, be comprised of a location where an untraineduser can perform a task or tasks, such as checking in for an appointmentor performing a requested test. This kiosk may be comprised ofelectronics or computer equipment, may be shielded from the view ofother people in the same room, may be comprised of seating, and mayprovide a material result to a user. Other kiosk configurations arepossible.

In another embodiment, the patient may register for the encounter withan office interface 210, such as a tablet computer, that is supplied bythe clinic and may have been configured with software to interface withthe encounter module 200. In still another embodiment, the user mayregister for the encounter with their own portable device, such as amobile phone or tablet computer, that can be configured with softwarethat can allow it to act as either or both an office interface 210 or asa patient interface 250.

In various embodiments, orders or steps in an electronic encountersystem can include, for example, asking a patient to sit in waiting area310, asking a patient to proceed to testing area 320 or asking a patientto go to clinic area 330. These orders can be conveyed to the patientby, for example, the patient interface 250 or by office personnel. Inone embodiment, the desired disposition for a patient can be determinedby a clinic process 205 that may have been entered into the encountermodule 200 and communicated to the patient via the patient interface 250or office personnel.

In one embodiment, the patient interface 250 can be configured to useinformation from the tracking system 240 for example, to determine thelocation of the patient in the clinic, to determine the next plannedlocation for a patient from a clinic process 205 in the encounter module200, or to communicate directions to a patient using the patientinterface 250.

Referring to FIG. 10, in one embodiment 340, a line can be drawn on aschematic map of the clinic space on patient interface 250 to show thepatient how to walk to their next destination in the clinic. In anotherembodiment, the patient interface 250 can be configured to communicatedirections verbally, such as by text-to-speech software.

In one embodiment, the encounter module 200 may be configured to monitorwhich rooms and devices in an office are “in use” based on informationprovided by the tracking system 240. In one embodiment, the encountermodule 200 may be configured to select a next location for a patientbased on which rooms or devices 260 may be free to use. For example, ifthe encounter module 200 determines that a device 260 required for thenext stage of a clinic process 205 is occupied or busy, the encountermodule 200 can be configured to alter the clinic process 205 byinserting, for example, a waiting room order that, for example, can beremoved from the clinic process 205 when the required device is free foruse.

In one embodiment, the encounter module 200 can be configured to monitorutilization of a device 260 or clinic area that may be required for thenext stage of a clinic process 205 and may be configured to insert anorder for a patient to move to that device 260 or clinic area when itbecomes free for use.

In another embodiment, the encounter module 200 can be configured tomonitor the list of patients waiting for a provider and also todetermine which providers have the shortest waiting lists or waitingtimes based on, for example, the number of patients in a waiting patientlist and the average time the provider spends with each patient. Theencounter module 200 can be configured to use this information, forexample, to assign patients to providers with the shortest wait times soas to improve clinic flow. Numerous other embodiments of devicedecisions based on dynamic knowledge of device and space utilizationwithin an office space are possible.

An example of a healthcare encounter is shown in FIG. 11. In oneembodiment, the first step in the encounter may be registration 400which can be completed, for example, by office staff or by the patientusing, for example, an office interface 210. Encounter registration 400may be comprised of many steps such as signing the patient's name andaddress, presenting identification, verifying insurance status, payingco-payments due prior to the encounter, consenting to be seen by theprovider, consent to privacy regulations or payment of other fees. Inother embodiments, the user may skip registration 400 and may proceed toother steps, such as examination 410.

In one embodiment, one step in an automated healthcare encounter can beverification of the user's identity. This may be accomplished, forexample, as part of registration 400, as part of examination 410, priorto using any device 260, or at other times in the encounter. A mobilepatient interface 250 may be advantageous since it can verify the user'sidentity once and then communicate this identity to, for example, theencounter module 200, to providers, or to subsequent devices usedthroughout the encounter, such as devices 260.

In various embodiments, the patient interface 250 can be configured toverify the user's identity through biometrics, such as throughrecognition of the patient's face, voice, fingerprint or other uniquephysical aspects of the subject. In other embodiments, the patientinterface 250 can be configured to verify the user's identity throughconfirmation of a user's unique data, such as their names, date ofbirth, addresses, mother's maiden name, or answers to questions onlyknown to the user. In another embodiment, the patient interface 250 canbe configured to verify the user's identity through confirmation ofcode, such as a password or secret code known only to the user. In stillanother embodiment, the patient interface 250 can be configured toverify the user's identity through coupling of a device carried only bythe user, such as a key, electronic device, bar code or QR code.

In one embodiment of an electronic healthcare encounter, the user maycomplete the history portion of their examination as part of theiroverall encounter. As discussed previously, in various embodiments, thehistory portion of the encounter can be collected, for example, byoffice staff or by the patient themselves. Office staff may use thepatient interface 250 or the office interface 210 to conduct or enterresults from a patient history. In other embodiments, the patient mayuse the patient interface 250 to complete their own history withoutinteracting with office staff.

In various embodiments, the questions can be configured in a form thatfacilitates responses using written, mouse-based, tablet-based or voiceentry such as multiple choice, true or false, or pull-down menuselections. In other embodiments, the questions may require free entrysuch as by writing, voice dictation, or keyboard entry. In theseexamples, the patient interface 250, the office interface 210 or theencounter module 200 may be configured to interpret electronic forms ofthese inputs, such as electronic writing or voice dictation.

In one embodiment, the history portion of the encounter may be comprisedof a standard series of questions. In another embodiment, the series ofquestions may be based on, for example, a preference specified by theprovider, the patient's diagnosis, the patient's symptoms or some otherunique aspect of the encounter.

In still another embodiment, the history portion of the encounter can becomprised of questions from a database whereby the next question to beasked can be determined, for example, based on an answer to a previousquestion. This dynamically-traversed database of questions may useanswers from a question to determine subsequent questions to ask or todetermine sets of questions to ask based on a tree organization ofquestions in the database. For example, if a patient reports colorvision loss, the system can be configured to add a series of questionsrelated to color vision loss to its list of questions even if they werenot previously included in the set of questions to be asked. In laterquestioning, it the patient reports pain on eye movement, the system canbe configured to add, for example, questions related only to pain on eyemovement or questions related to pain on eye movement and color visionloss. The dynamic allocation of new questions based on answers toprevious questions can be configured such that a provider can allow ordisallow such a feature.

In one embodiment, a dynamically-traversed electronic questionnaire canbe configured to assign priority values to each question so that certainquestions can be asked before other questions. In still anotherembodiment, the system can provide a running count of the total numberof questions to be asked to the patient along with an estimated totaltime to completion. In related embodiments, the system can be configuredto allow users or providers to shorten the questionnaire, such as byexcluding lower priority questions, based on aspects of the dynamicquestionnaire such as it taking too much time or involving too manyquestions and answers.

In another embodiment, the patient interface 250 can be configured toallow the user to change display parameters, such as size, color andfont type, used to display questions with the patient interface 250. Inother embodiments, the patient interface 250 can be configured to readquestions aloud, for example using a text-to-speech system orpre-recorded voices, or to ensure privacy by providing a headphone jackwhere the user can connect headphones.

In one embodiment, the encounter module 200 can be configured to directdevices 260 to perform tests and store results associated with theclinic process 205 and the patient's information contained within theencounter module 200. The encounter module 200 can be configured tocommunicate with these devices 260 using a direct wired connection, suchas a USB, Ethernet or serial connection, a wireless connection, such asBluetooth® or 802.11, an intermediate electronic device, such as a USBkey, memory card or patient interface 250, or a physical codedembodiment such as a bar code or QR code.

In one embodiment, the encounter module 200 or patient interface 250 canbe configured to alter the list of tests requested for an encounterbased on answers to history questions or results from testing on devices260. The encounter module 200 or the patient interface 250 can also beconfigured to direct a device 260 to conduct a new test or tests inaddition to or in place of the old test or tests. Alteration of theclinic process 205 by the encounter module 200 or patient interface 250can be allowed or disallowed by a provider either globally orspecifically, such as based on answers to specific questions orcategories of questions, using, for example, the office interface 210.

In one embodiment, the encounter module 200 or the patient interface 250can be configured to initiate operation of a device 260, such as aninstrument to measure vision. In another embodiment, the encountermodule 200 or the patient interface 250 can be configured to allow theuser to initiate operation of a device 260, such as by saying “ready”,pushing a button or pressing a pedal that may be attached to the patientinterface 250. In still another embodiment, the encounter module 200 orthe patient interface can be configured to allow the user to initiateoperation of the device 260, such as by saying “ready”, pushing a buttonor pressing a pedal, through the device 260.

As discussed previously, the encounter module 200 or the patientinterface 250 can be configured to receive data, such as examinationresults, from devices, such as the tracking system 240, the patientinterface 250 or devices 260. As discussed above, the encounter module200 can be configured to communicate with these other components using,for example, a wired connection, a wireless connection, an intermediateelectronic, or using a physical embodiment.

Collection of data from numerous devices by the patient interface 250 orencounter module 200 can be particularly advantageous by reducingtranscription or sorting errors that can occur when human laborers areinvolved in these processes or by centralizing all encounter data in onelocation.

Various components in the electronic encounter system, such as theencounter module 200, can be configured to compile encounter data into adigital package or packages that can be uploaded to, for example, anelectronic health record system either in the office, such as the officedatabase 220, or outside the office via secure external communication235, transmitted to other individuals on a patient's healthcare team viasecure external communication 235, reviewed directly by the provider ona patient interface 250 or office interface 210, or stored on anaccessible external database 230. The external database 230 can beconfigured to be accessible remotely, such as via the Internet, forexample, to facilitate sharing of exam data between providers or tofacilitate access by the patient to their own healthcare data.

As discussed previously, the encounter module 200 can be configured totrack both patients and clinic personnel using the tracking system 240.The encounter module 200 can be configured to store tracking informationsuch that it, for example, can be viewed or analyzed using an officeinterface 210. By tracking a patient's location over time, the encountermodule 200 can be configured to develop clinic patient flow maps thatmay enable staff to identify both acute and chronic problems with clinicflow. For instance, identification of a patient by the encounter module200 who has been waiting longer than a pre-defined threshold valuestored in a clinic process 205 can alert the staff, for example via anoffice interface 210, to address problems with that patient's encounterthat might be leading to this delay. Identification of chronicbottlenecks and waiting points across numerous encounters can allowpractices to optimize their workflow.

Providers can be tracked in several ways. In one embodiment, mobileoffice interfaces 210 can be configured with tracking systems 240 toidentify the location and identity of providers carrying them. Inanother embodiment, the patient interface 250 can be configured torequire providers to log in whenever they are consulting with a patient.In still another embodiment, the tracking system 240 can be configuredto monitor the location or identity of providers wearing identifiers,such as RFID tags. In other embodiments, the encounter module 200 couldbe configured to communicate updates to patients, such as by using thepatient interface 250, to, for example, estimate the approximate waittimes until the provider sees them or to convey how many patients stillneed to be seen by the provider before they are seen by the provider.

The electronic encounter portal can also be configured to provideentertainment or education to a patient. For example, the patientinterface 250 can be configured to provide Internet access 235, accessto previous encounter records stored on the encounter module 200, oraccess to previous encounter records stored on the external database230. The patient interface 250 can also be configured to provide accessby the patient to educational resources, potentially targeted toward thediagnosis or future treatments for a patient, that may be stored oncomponents such as the encounter module 200. In one embodiment, theprovider can use a patient interface 250 or an office interface 210 toenter orders for an educational program into a clinic process 205.

In another embodiment, the patient interface 250 can be used to inform apatient about clinic resources, such as clinical trials, supportprograms, therapeutic services, restrooms, refreshments, etc. based oninformation stored on the encounter module 200. The encounter module 200can also be configured to direct patients to these resources, such asrestrooms, based on information from the tracking system 240 andrequests from the patients using the patient interface 250. Theencounter module 200 can also be configured to manage communicationsbetween patients, using a patient interface 250 and office staff, suchas by using an office interface 210.

In one embodiment, the patient interface 250 can be configured to storedata from devices and, in an embodiment that is mobile such as a tabletor smartphone, can allow the patient to transport encounter data throughthe clinic process 205 for review by or with the provider. In anotherembodiment, the office interface 210 can be configured to enable data tobe uploaded for review by the provider. Both the patient interface 250and the office interface 210 can be configured to access and use priorvisit data from the encounter module 200 to enhance assessments of apatient's healthcare status. Similarly, both the patient interface 250and the office interface 210 can be configured to access prior data fromthe external database 230 to enhance assessments of a patient'shealthcare status.

In related embodiments, the encounter module 200 and the externaldatabase 230 can be configured to act as common locations for encounterdata that can be accessed by both patients and providers. The externaldatabase 230 can be configured to allow remote access to encounter databy both providers and patients when they are outside of the office.Similarly, the external database 230 can be configured to receive datafrom devices 260 at locations outside of the described office and sharethese results with the encounter module 200 for example, to enableautomated remote healthcare encounters.

In one embodiment of an electronic encounter portal, a check-outprocedure 420 may be the last order or step in a clinic process 205. Invarious embodiments, the office interface 210 or the patient interface250 can be configured to allow providers to enter orders for futureencounters such as testing or therapies. In other embodiments, theoffice interface 210 can be configured to enable the provider to enterbilling information to be submitted for insurance reimbursement ordirectly charged to the patient. In still another embodiment, the officeinterface 210 can be configured to allow the provider to recommend afollow-up interval for the next encounter. In a related embodiment, theoffice interface 210 or the patient interface 250 can be configured toallow the patient to select the best time and data for a follow-upencounter. In another embodiment, the office interface 210 can beconfigured to allow the provider to order educational materials oreducational sessions for the patient that may occur after the encounterconcludes.

Accordingly, various embodiments described herein can reduce the needfor clinic personnel to perform these tasks. In addition, variousembodiments enable users to conduct their own complete eye exams.

Automated Eye Examination

FIG. 12 shows an example of a binocular eye examination system based onoptical coherence tomography. Component 500 may be comprised of the mainelectronics, processors, and logic circuits responsible for control,calculations, and decisions for this optical coherence tomographysystem. Light can be output from light source 502 which may becontrolled at least in part by component 500. The light source may becomprised of a broadband light source such as a superluminescent diodeor tunable laser system. The center wavelength for light source 502 canbe suitable for optical coherence tomography of the eye, such as 840 nm,1060 nm, or 1310 nm. The light source 502 may be electronicallycontrolled so that it can be turned on, off or variably attenuated atvarious frequencies, such as 1 Hz, 100 Hz, 1 kHz, 10 kHz or 100 kHz. Inone embodiment, light from light source 502 can travel throughinterferometer 504, which may be comprised of a Mach Zender or othertype of interferometer, where a k-clock signal can be generated. Thiselectronic signal can be transmitted to electronics on component 500 orother components in the system and can be captured on a data acquisitionsystem or used as a trigger for data capture.

The k-clock signal can be used as a trigger signal for capturing datafrom balanced detectors 518 r and 518 l. Alternatively, the k-clocksignal can be captured as a data channel and processed into a signalsuitable for OCT data capture. This k-clock signal can be captured allof the time, nearly all of the time or at discrete times after which itwould be stored and recalled for use in OCT capture. In someembodiments, various parameters of the k-clock signal, such as frequencyor voltage, can be modified electronically, such as doubled orquadrupled, to enable deeper imaging in eye tissues. In variousembodiments with light sources that sweep in a substantially linearfashion, the k-clock can be removed and a regular trigger signal may beemployed. In various embodiments, the trigger signals used byelectronics 595 r and 595 l may be synchronized with other components ofthe system, such as mirrors, variable focus lenses, air pumps andvalves, pressure sensors and flow sensors.

Most of the light, such as 90% or 95%, that enters the interferometer504 can be transmitted through interferometer 504 to a beam splitter orcoupler 510. As used herein, “coupler” may include splitters as well ascouplers. Beam coupler 510 can split the light from interferometer 504or light source 502 to two output optical paths, specifically right andleft, that lead directly to couplers 515 r and 515 l. Henceforth,designation of a device or component with a suffix of ‘r’ or ‘l’ willrefer to two devices that may be of the same type but are located indifferent optical paths. For example, one component may be located inthe optical path of the right eye, designated as ‘r,’ and the other islocated in the optical path of the left eye, designated as ‘l.’

The optical paths in this system may be comprised of fiber optics, freespace optics, a mixture of free space and fiber optics. Othercombinations are also possible. The split ratio of coupler 510 can be apredefined ratio, such as 50/50 or 70/30. Light from coupler 510 cantravel to couplers 515 r and 515 l. Couplers 515 r and 515 l may alsosplit light from coupler 510 with a predefined split ratio such as a50/50, 70/30, or 90/10. The split ratios for couplers 510, 515 r and 515l may be the same or different split ratios.

One portion of light from couplers 515 r and 515 l, such as 70%, cantravel to a so-called ‘reference arm’ for each of the right and leftoptical paths. The reference arm of a light path is distinguished fromthe so-called sample arm of the light path since light in the referencearm of the system does not interface with eye tissue directly whereaslight in the sample arm is intended to contact eye tissue directly.

The main component in the reference arm may be an optical delay device,labeled as 516 r and 516 l in the right and left optical paths of thesystem. Optical delay devices can introduce a delay, such as 1picosecond, 10 picoseconds or 100 picoseconds, into a light path toenable matching of the overall path length of one optical path to theoptical path length of another light path. In various embodiments, thisoptical delay may be adjustable, such as with an adjustable free lightpath between two collimating optical devices, a fiber stretcher thatincreases or decreases the length of a fiber optic, or a fiber Bragggrating that delays light based on changes in the angle of incidence oflight.

In other embodiments, this optical delay line can include variableattenuators to decrease or increase the transmission of light, opticalswitches or mechanical shutters to turn the light off or on. Althoughpictured in the reference arm of this system, an optical delay line canalso be entirely included in the sample arm optical path for each eye orcontained in both the reference and sample arm light paths. Othercombinations of sample and reference light paths are also possible.

In one embodiment, light from optical delay devices 516 r and 516 l cantravel to couplers 517 r and 517 l where it may be combined with lightfrom the sample arm that has been transmitted from couplers 515 r and515 l. Couplers 517 r and 517 l may combine light from two light pathswith a predefined ratio between paths such as a 50/50, 70/30, or 90/10.Light from couplers 517 r and 517 l may travel through two outputs fromcouplers 517 r and 517 l to balanced detectors 518 r and 518 l where thelight signal can be transformed into an electrical signal, for examplethrough the use of photodiodes configured to detect the light input fromcouplers 517 r and 517 l.

The electrical signal generated by balanced detectors 518 r and 518 lcan be in various ranges, including but not limited to −400 mV to +400mV, −1V to +1V, −4V to +4V and have various bandwidths, including butnot limited to 70 MHz, 250 MHz, 1.5 GHz. The electrical signal frombalanced detectors 518 r and 518 l may travel via an electricalconnection, such as a coaxial cable, to electronics 595 r and 595 lwhere it can be captured by a data acquisition system configured tocapture data from balanced detector devices. Although not pictured here,a polarization sensitive optical component can be disposed beforebalanced detectors 518 r and 518 l to split two polarities of light in asingle light path into two optical paths. In this embodiment, twooptical paths leading to balanced detectors 517 r and 517 l would besplit into a total of four optical paths which would lead to twobalanced detectors on each side.

One portion of light from couplers 515 r and 515 l, such as 30% or 50%,can travel to a so-called sample arm of each of the right and leftoptical paths. In various embodiments, the system may be configured totransmit the light through fiber optic cable or through free spaceoptics. Light from couplers 515 r and 515 l can travel to optics 520 rand 520 l which may be collimators configured to collimate the lightfrom couplers 515 r and 515 l. Light from optics 520 r and 520 l cantravel to lens systems 525 r and 525 l which may be comprised of fixedfocus or variable focus lenses.

In various embodiments, these lenses can be fabricated from plastic orglass. In other embodiments, these lenses may be electrowetting lensesor shape-changing lenses, such as fluid-filled lenses, that can varytheir focal distance based on internal or external control mechanisms.In one embodiment, variable focus lenses in lens systems 525 r or 525 lmay have their focal length modified by electrical current or voltageapplied to lens systems 525 r or 525 l. This control may come fromelectrical components 595 r and 595 l and the parameters of this controlmay be based on pre-determined values or may be derived during operationof the system based on input received from other components of thesystem.

The lenses in lens systems 525 r and 525 l can be configured to haveanti-reflective coatings, embedded temperature sensors, or otherassociated circuitry. Lens systems 525 r and 525 l may be comprised of asingle lens or multiple lenses. The lenses comprising systems 525 r and525 l may be present at all times or may be mechanically moved in andout of the light path such as by an attached motor and drive circuitunder electrical control from components 595 r and 595 l. Configurationof lens systems 525 r and 525 l to be moveable can enable imaging atdifferent depths in an eye tissue by introducing and removing vergencein the optical system.

Light from lens systems 525 r and 525 l can travel to movable mirrors530 r and 530 l. Movable mirrors 530 r and 530 l may be comprised ofMEMS (microelectromechanical systems) mirrors, controlled bygalvanometers, or moved by other means. Movable mirrors 530 r and 530 lcan be comprised of a single mirror that reflects light across 2 axes,such as X and Y, can be comprised of a single mirror that reflects lightacross one axis only, or can be comprised of two mirrors that eachreflect light across one axis only said axes being substantiallyperpendicular to each other.

Electrical control of mirrors 530 r and 530 l, which may control eachaxis of reflection independently, can be provided by components 595 rand 595 l. The electronic control of mirrors 530 r and 530 l may beconfigured to enable variable amplitude deflections of mirrors 530 r and530 l. For example, for a given drive frequency in a given axis, thecurrent or voltage applied to mirrors 530 r and 530 l may enable largeror smaller amplitude deflections of the mirror surface, thus creating azoom effect where the created image can be made smaller or larger.

Light that has been reflected from movable mirrors 530 r and 530 l cantravel to lens systems 535 r and 535 l. Lens systems 535 r and 535 l maybe fixed or variable focus lenses that are located in the optical lightpath at all times or only part of the time. Electrical control of lenses535 r and 535 l, can be conducted by components 595 r and 595 l and mayinclude for example moving these lenses in and out of the light path orchanging their focal lengths. Other actions are also possible.

Light from lens systems 535 r and 535 l can travel to optics 540 r and540 l which may be comprised of dichroic mirrors or couplers. Optics 540r and 540 l may be configured to transmit light from lens systems 535 rand 535 l and combine it with light from lens systems 545 r and 545 l.Light from optics 540 r and 540 l can travel to eye pieces 542 r and 542l before being transmitted to the right and left eye tissues.

Eye pieces 542 r and 542 l can be configured as multi-element lenssystems such as Ploessel-type eyepieces, Erfle-type eyepieces,telescopes or other designs. In some embodiments, optics 540 r and 540 lmay be configured to be part of or inside of eyepieces 542 r and 542 l.In other embodiments, variable focus lenses or polarization-sensitiveoptics and beam splitters can be configured inside eyepieces 542 r and542 l to enable wider axial focusing ranges in eye tissues orsimultaneous focusing of light from two axial locations in eye tissues.Eyepieces 542 r and 542 l may be configured with optical componentswithout any refractive power, such as optical windows, that may bephysically attached or separate from the other lenses in the system.

Light entering the right and left eyes can be reflected back througheach optical path to enable optical coherence tomography. In oneembodiment, the path of backreflected light originating from lightsource 502 can travel from each eye to eyepiece 542 to optics 540 tolens system 535 to movable mirror 530 to lens system 525 to optics 520to coupler 515 to coupler 517 to balanced detector 518. Variouscalculations and logic-based processes can be completed by components595 r and 595 l based on data contained in signals received frombalanced detectors 518 r and 518 l.

As discussed previously, timing of capture of the signals received bycomponents 595 r and 595 l may be controlled by other inputs, such asthe k-clock input, dummy clock input, or other electrical signal.Electronics 500, 595 r, and 595 l may be configured to have digitalsignal processors (DSPs), field-programmable gate arrays (FPGAs), ASICsor other electronics to enable faster, more efficient or substantiallyreal-time processing of signals received by components 595 r and 595 l.Electronics 500, 595 r, and 595 l may be configured with software, suchas a real-time operating system, to enable rapid decisions to be made bysaid components.

In various embodiments not illustrated here, the eye tissues may bereplaced by calibration targets that, for example, occlude theeyepieces, dispose a mirror target at various distances in front of theeyepieces, or provide an open air space for calibration. Electronics 500may be configured to control the introduction of these non-tissuetargets, such as when the eyes are not present in the optical system. Inother embodiments, electronics 500 may be configured to dispose poweredor moveable components of the system to various states, such as “off,”“home,” or “safety” at various times, such as the beginning, middle andend of a test.

Components 595 r and 595 l can also be configured to control lightsources 585 r-588 r and 585 l-588 l which may be comprised of variouslight sources such as for example, laser diodes, light emitting diodes,or superluminescent diodes. In the illustrated embodiment, only fourlight sources 585 r-588 r and 585 l-588 l are shown. In variousembodiments, different numbers of light sources 585 r-588 r and 585l-588 l may be used and different wavelengths of light sources may beused. In one embodiment, one each of a blue-colored, green-colored,red-colored and near infrared diode can be included in the light sourcegroups 585 r-588 r and 585 l-588 l.

In other embodiments, light sources 585 r-588 r and 585 l-588 l may becomprised of tunable light sources capable of producing numerous spectraof light for the purposes of hyperspectral imaging. For example,employing various light sources in the visible spectrum capable ofproducing narrow bands of light centered at characteristic peaks ofabsorption or reflectivity for oxyhemoglobin and deoxyhemoglobin can beused to enable hyperspectral imaging. Similarly, numerous individuallight sources can be used to achieve the same effect as a light sourcewith a tunable wavelength.

These light sources can be configured to be controlled by components 595r and 595 l using, for example, pulse-width modulation, currentmodulation, voltage modulation, or other electrical control means. Inone embodiment, the modulation frequency of at least one light sourcecan be modified to correct for chromatic aberration from the opticsbetween the light sources and the eye. For example, the modulationfrequency of the red channel could be variably increased or decreased indifferent mirror positions to account for lateral chromatic spreadbetween the red light source and other colors such as blue or green.

Light from light sources 585 r-588 r and 585 l-588 l can travel tooptics 580 r-583 r and 580 l-583 l which may, for example, be focusingoptics. Light from optics 580 r-583 r and 580 l-583 l can then travel tooptics 575 r-578 r and 575 l-578 l which may, for example, be focusingoptics. Each path of light can contain a single frequency of light, suchas 450 nm, 515 nm, 532 nm, 630 nm, 840 nm, or 930 nm or multiplefrequencies of light.

Each path of light from light sources 585 r-588 r and 585 l-588 l may bereflected off optics 571 r-574 r and 571 l-574 l which may, for example,be dichroic mirrors or couplers and may be specifically configured toreflect and transmit light based on their position in the optical path.For example, one optic may be configured to transmit light with awavelength less than 500 nm and reflect light with a wavelength greaterthan 500 nm.

Optics 571 r-574 r and 571 l-574 l can be configured to join togetherlight from different light sources 585 r-588 r and 585 l-588 l into asingle, substantially coaxial beam of light that can travel to optics561 r and 561 l. Optics 561 r and 561 l may be dichroic mirrors orcouplers and may be configured to have a pre-defined split ratio oflight entering from different directions or having differentwavelengths, such as 90/10, 50/50, and 10/90.

A portion of light from optics 571 r-574 r and 571 l-574 l can betransmitted through optics 561 r and 561 l to sensors 566 r and 566 lwhich may, for example, be photodiodes or other components capable ofsensing light. Signals from sensors 566 r and 566 l can be configured tobe transmitted along electrical connections between sensor 566 r andelectrical component 595 r on the right side and sensor 566 l andelectrical component 595 l on the left side. In one embodiment, sensors566 r and 566 l can be configured to monitor the total light power beingemitted by light sources 585 r-588 r and 585 l-588 l.

The portion of light reflected off optics 561 r and 561 l from optics571 r-574 and 571 l-574 l can travel to lens systems 560 r and 560 l.Lens systems 560 r and 560 l may be comprised of fixed focus or variablefocus lenses. In various embodiments, these lenses can be fabricatedfrom plastic or glass. In other embodiments, these lenses may beelectrowetting lenses or shape-changing lenses, such as fluid-filledlenses, that may vary their focal distance based on internal or externalcontrol mechanisms.

In one embodiment, variable focus lenses in lens systems 560 r and 560 lmay have their focal length modified by electrical current or voltageapplied to the lens systems. This control may be under the direction ofelectrical components 595 r and 595 l and it may be based onpre-determined values or be derived during operation of the system basedon input received from other components of the system.

The lenses in lens systems 560 r and 560 l can be configured to haveanti-reflective coatings, embedded temperature sensors, or otherassociated circuitry. Lens systems 560 r and 560 l may be comprised of asingle lens or multiple lenses. The lenses comprising systems 560 r and560 l may be present in the light path at all times or may bemechanically moved in and out of the light path by an attached motor anddrive circuit under electrical control from components 595 r and 595 l.Configuration of lens systems 560 r and 560 to be moveable can enableimaging at different depths in an eye tissue by introducing and removingvergence in the optical system.

Light from lens systems 560 r and 560 l can travel to lens systems 555 rand 555 l. In some embodiments, lens systems 555 r and 555 l can belocated in their respective optical paths at all times. In otherembodiments, lens systems 555 r and 551 may be moved in and out of theoptical paths based on electrical signals from components 595 r and 595l.

Light from lens systems 555 r and 555 l can travel to movable mirrors550 r and 550 l. Movable mirrors 550 r and 550 l may be comprised ofMEMS mirrors, controlled by galvanometers, or moved by other means.Movable mirrors 550 r and 550 l can be comprised of a single mirror thatreflects light across 2 axes, such as X and Y, can be comprised of asingle mirror that reflects light across one axis only, or can becomprised of two mirrors that each reflect light across one axis onlysaid axes being substantially perpendicular to each other.

Electrical control of mirrors 550 r and 550 l, which can control eachaxis of reflection independently, can be provided by components 595 rand 595 l. Mirrors 550 r and 550 l may have one axis of fast resonantmovement, one axis of slow resonant movement, two slow axes of movement,one fast resonant axis and one slow axis of movement, or two fastresonant axes of movement.

The electronic control of mirrors 530 r and 530 l may be configured toenable variable amplitude deflections of mirrors 530 r and 530 l. Forexample, for a given drive frequency in a given axis, the current orvoltage applied to mirrors 530 r and 530 l may enable larger or smalleramplitude deflections of the mirror surface, thus creating a zoom effectwhere the created image can be made smaller or larger.

Light from movable mirrors 550 r and 550 l can travel to lens systems545 r and 545 l. Lens systems 545 r and 545 l may be configured tointroduce variable amounts of optical cylinder power into the opticallight paths. In one embodiment, the magnitude and axis of thecylindrical optical power introduced into the optical paths by lenssystems 545 r and 545 l can be configured to correct an astigmatismpresent in an eye interfacing with this system.

Lens systems 545 r and 545 l can comprised of two cylindrical lensesconfigured to counter-rotate and co-rotate with each other, anelectrically controlled variable focus, liquid filled lens, or othermethod of introducing cylindrical optical power into a light path.Although not illustrated here, lens systems 545 r and 545 l can also belocated between mirrors 530 r and 530 l and optics 540 r and 540 l inthe OCT light path.

Light from lens systems 545 r and 545 l can travel to optics 540 r and540 l where it may be reflected to combine with light originating atlight source 502. In one embodiment, an exit pupil expander can bedisposed between moveable mirrors 550 r and 550 l and the eye tissues toincrease the size of the exit pupil created at the eye tissue by mirrors550 r and 550 l.

Light from lens systems 545 r and 545 l may be transmitted througheyepieces 542 r and 542 l after which it may enter the right and lefteyes of a subject. Light transmitted through eyepieces 542 r and 542 lcan be configured to be seen by the subject as organized light, such asin a retinal scanning display system, can be configured to be seen bythe subject as video-rate imaging through modulation of light sources585 r-588 r and 585 l-588 l by components 595 r and 595 l, or can beconfigured to broadly stimulate the eye with light such as formeasurements of pupillary reactions to light stimuli.

Light from lens systems 545 r and 545 l can also be configured toreflect back out of the eye and through eyepieces 542 r and 542 l, offoptics 540 r and 540 l, through lenses systems 545 r and 545 l, offmoveable mirrors 550 r and 550 l, through lens systems 555 r, 555 l, 560r, and 560 l and then through optics 561 r and 561 l. Light transmittedthrough optics 561 r and 561 l can be detected by sensors 567 r-570 rand 567 l-570 l which may, for example, be comprised of photodiodes.

In various embodiments, this light is split into predefined wavelengthbands, such as 440 nm-460 nm, 510 nm-580 nm, 625 nm-635 nm, or 930 nm,by dichroic mirrors 562 r-565 r and 562 l-565 l. In other embodiments,separation of light from optics 561 r and 561 l into bands can beachieved by the use of filters that selectively transmit or reflectwavelength bands of interest.

In still other embodiments, separation of light from optics 561 r and561 l into bands can be achieved by configuring the system with sensors567 r-570 r and 567 l-570 l that only produce electrical signals inspecifically targeted bands, such as 400-500 nm, 600-800 nm or >900 nm.Electrical signals from sensors 567 r-570 r and 567 l-570 l can travelto components 595 r and 595 l across electrical connections to enableimaging of tissues in the eye by sensing the light originating at lightsources 585 r-588 r and 585 l-588 l backreflected in desired wavelengthbands.

FIG. 13 shows an example of a display of eye examination data on anelectronic device 600. In some embodiments, the display system enablesviewing and comparing of data from two eyes of one patient acrossmultiple tests and dates in a minimal amount of space. Accordingly, someembodiments enable the user to collapse undesirable test or date fieldsso as to maximize the display area of desired measurements.

Device 600 may be a portable computing platform, such as a smartphone ora tablet, or be a stationary computing platform with a display screen.Device 600 may allow touch screen operation, eye tracking operationwhere eye movements are interpreted as cursor movements on the device600 itself or operation with standard computing peripherals such as amouse and keyboard.

Data in the illustrated grid can be populated by software from adatabase of examination data that may, for example, include exams frommany patients on many days. Accordingly, software running on device 600can be configured to enable searching or selection of the patient whoseexam data is to be displayed in the illustrated display configuration.

Software on device 600 can be configured to output exam data in asubstantially tabular format comprised mainly of rows 612 and columns614. In various embodiments, the software can be configured to includeall exam data for a given date in one column 614 while all measurementsfrom a given test can be included in a single row 612. The software canalso enable preferences that allow transformation of this rule such thatdates are in rows 612 and tests are in columns 614. In some embodiments,each box in the table representing an intersection of a row 612 and acolumn 614 can be represented as a field populated with, for example, anumerical measurement, a text value or an image. Although the fields arelabeled generically in FIG. 6, it will be appreciated that a variety ofdata, such as numbers, text or images, can be displayed in each field.

Field 610 can be configured to contain information on the patient, suchas name, date of birth, medical record number, age, gender. Although notillustrated here, field 610 may also be used to open pop-up windows thatcan be used to search or configure the exam display system.

Fields 620-625 can be configured to contain dates of exams for a givenpatient. In one embodiment, clicking of a column heading 620-625 togglesthe column between collapsed and expanded configurations where data isnot displayed in the collapsed configuration but data is displayed inthe expanded configuration. In FIG. 6, columns 620, 623 and 625demonstrate expanded fields while columns 621, 622 and 624 representcollapsed fields. Thus, the fields in the collapsed columns 621, 622,624 may be collapsed. For example, fields 650, 651, 652, 653, 654 may becollapsed when column 621 is collapsed. The software can be configuredto allow users to toggle this display setting with, for example, asimple click of a column heading or other selection process.

Fields 630-634 can be configured to contain individual tests conductedon a given patient. In one embodiment, clicking of a row heading 630-634toggles the row between collapsed and expanded configurations where datais not displayed in the collapsed configuration but data is displayed inthe expanded configuration. In FIG. 6, rows 631 and 634 demonstrateexpanded fields while rows 630, 632 and 633 represent collapsed fields.Thus, the fields in the collapsed rows 630, 632, 633 may be collapsed.For example, fields 640, 650, 660, 670, 680, and 690 may be collapsedwhen row 630 is collapsed. The software can be configured to allow usersto toggle this display setting with, for example, a simple click of arow heading or other selection process.

In FIG. 13, it can be appreciated that two special rows can existcorresponding to the right (OD) and left (OS) eye headings. The softwarecan be configured to collapse or expand all tests for a given eye whenthat row heading, such as OD or OS, is clicked or otherwise selected.

Referring to FIG. 13, fields 641, 644, 671, 674, 691, and 694 can beconfigured to display data, such as numbers, text or images. In oneembodiment, display of images in these fields enables the user to clickon the images to bring up a larger window in which to view the images.In another embodiment, display of numbers in these fields enables theuser to click on the numbers to bring up a graph of the numbers, such asgraph over time with the dates in the column headers as the x-axis andthe values in the rows as the y values.

The software can be configured to show collapsed fields (e.g. field 640,650, 660, 651, 661) in a different color or in a different size. Thesoftware can also be configured to display scroll bars when fieldsextend off the display screen. For example, if more tests exist in thevertical direction than can be displayed on a single screen, thesoftware can be configured to allow panning with finger movements orscrolling with, for example, vertical scroll bars. The software can beconfigured to enable similar capabilities in the horizontal direction aswell.

What is claimed is:
 1. A mask, comprising: a distal sheet member havingone or more optically transmissive sections; a proximal inflatablemember having a rear concaved surface that faces a first patient's facewhen in use, wherein the rear concaved surface is configured to conformto contours of the first patient's face; the inflatable member havingtwo cavities therein, wherein each of the two cavities is aligned withone of the patient's eyes when in use, wherein the two cavities extendfrom the rear concaved surface toward the distal sheet member such thatthe two cavities define two openings on the rear concaved surface;wherein the rear concaved surface is configured to seal against thefirst patient's face such that the first patient's eyes are aligned withthe two cavities, so that the rear concaved surface forms seals around aperipheral region of the first patient's eye sockets that inhibit flowof fluid into and out of the cavities; an ocular port providing accessto at least one of the two ocular cavities for fluid flow into and outof the at least one of the two ocular cavities; and an inflation portproviding access to inflate the inflatable member.
 2. The mask of claim1, wherein the rear concaved surface is configured to conform to thecontours of the first patient's face with inflation of the inflatablemember via the inflation port.
 3. The mask of claim 1, wherein theinflatable member is underinflated, wherein the rear concaved surface isconfigured to conform to the contours of the first patient's face withinflation of the underinflated inflatable member via the inflation port.4. The mask of claim 1, wherein the rear concaved surface is configuredto conform to the contours of the first patient's face with applicationof negative pressure to the inflatable member via the inflation port. 5.The mask of claim 1, further comprising particulate matter disposedwithin the inflatable member, wherein the particulate matter isconfigured to pack together with application of negative pressure to theinflatable member via the inflation port, so that the rear concavedsurface conforms to the contours of the first patient's face.
 6. Themask of claim 1, wherein the rear concaved surface is configured toconform to contours of a second patient's face, wherein a contour of thesecond patient's face is different from a contour of the first patient'sface.
 7. The mask of claim 1, further comprising a lip extending into atleast one of the two cavities from a perimeter of at least one of thetwo openings, the lip having distal ends curving toward the distal sheetmember in a default position, the distal ends configured to moverearwardly such that the lip seals against the user's face uponintroduction of positive pressure into the at least one of the twocavities.
 8. The mask of claim 1, wherein the distal sheet member isconfigured to interface with a medical device.
 9. The mask of claim 8,wherein the medical examination device is an eye exam device.
 10. Themask of claim 1, wherein the mask is configured to couple with a dockingportion on a medical device.
 11. The mask of claim 1, wherein theinflation port and the ocular port are configured to couple with conduitends on a medical device.
 12. The mask of claim 11, wherein the ocularport and the inflation port are configured to couple with the conduitends on the medical device simultaneously.
 13. The mask of claim 1,wherein the mask is deflatable.
 14. The mask of claim 1, wherein theinflatable member is opaque.
 15. A mask comprising: a distal sheetmember having one or more optically transmissive sections; a proximalpre-inflated member having a rear concaved surface that faces a firstpatient's face when in use, wherein the rear concaved surface isconfigured to conform to contours of the first patient's face; thepre-inflated member having two cavities therein, each of the twocavities being aligned with one of the patient's eyes when in use,wherein the two cavities extend from the distal sheet member to the rearconcaved surface such that the two cavities define openings on the rearconcaved surface; wherein the rear concaved surface is configured toseal against the first patient's face such that the first patient's eyesare aligned with the two cavities, so that the rear concaved surfaceforms seals around a peripheral region of the first patient's eyesockets that inhibit flow of fluid into and out of the two cavities; andan ocular port providing access to at least one of the two ocularcavities for fluid flow into and out of the at least one of the twoocular cavities.
 16. A system, comprising: a medical device housingcontaining a medical instrument therein, wherein the medical devicehousing is configured to interface with a mask; a pump assemblycomprising: one or more conduits; a pump configured to provide fluid toone or more conduit ends via the one or more conduits; and a pressuresensor configured to sense a pressure in an ocular cavity formed in aninflatable member of the mask; and a processor in electroniccommunication with the pump and the pressure sensor, wherein theprocessor is configured to: receive the pressure in the ocular cavity;and control operation of the pump.
 17. The system of claim 16, furthercomprising conduit ends on the medical device housing, wherein theconduit ends are configured to couple with a port on the mask.
 18. Thesystem of claim 16, wherein the medical device housing comprises adocking portion configured to couple with the mask.
 19. The system ofclaim 16, wherein the processor is configured to control operation ofthe pump based at least in part on the pressure in the ocular cavity.20. The system of claim 16, wherein the processor is configured todetermine an ocular measurement based at least in part on the pressurein the ocular cavity.
 21. The system of claim 16, further comprising avalve in fluid communication with the pump and in electroniccommunication with the processor, wherein the processor is configured tochange a state of the valve.
 22. A method, comprising: receiving, by acomputing system, patient distance information from a device configuredto provide distance information, wherein the distance information isindicative of a distance between a patient and a medical device, whereinthe patient is coupled to a mask comprising an inflatable chamber; andmodulating, by the computing system, inflation or deflation of theinflatable chamber based at least in part on a desired distance.
 23. Themethod of claim 22, further comprising determining, by the computingsystem, the desired distance based at least in part on a parameter of amedical examination, treatment, or diagnosis.
 24. The method of claim22, wherein the device configured to provide distance information is asensor.
 25. The method of claim 22, wherein the device configured toprovide distance information is an optical coherence tomography device.26. A method of taking ocular measurements, comprising: changing, by acomputing system, a pressure in an ocular cavity formed in an inflatablemember of a mask; receiving, by the computing system, an indication ofthe pressure in the ocular cavity; and determining, by the computingsystem, a change to an ocular measurement in response to the change inthe pressure in the ocular cavity.
 27. The method of claim 26, whereinthe ocular cavity defines an opening on a rear surface of the mask,wherein the rear surface is configured to seal against a patient's facesuch that the patient's eye is aligned with the cavity, so that the rearsurface forms seals around a peripheral region of the patient's eyesocket that inhibit flow of fluid into and out of the cavity.
 28. Themethod of claim 26, wherein changing the pressure in the ocular cavitycomprises controlling operation of a pump and/or changing a state of avalve; wherein the pump, the valve, and the mask are in fluidcommunication.
 29. The method of claim 26, wherein determining an ocularmeasurement comprises processing data received from optical imagingcomponents.